Manufacturer

Integra Limited

9 recalls in our database name Integra Limited as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2019-05-22

Of the 9 recalls from Integra Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

ModerateFDA (Devices)·Z-1338-2019·2019-05-22
Integra Flowable Wound Matrix Recalled for Stability Failure
Integra Limited is recalling 274 units of Integra Flowable Wound Matrix (Lot 2991332) because the product failed stability testing for visual appearance and force displacement.
Product
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehisce
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1090-2019·2019-04-17
Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.
Product
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1089-2019·2019-04-17
Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.
Product
Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1091-2019·2019-04-17
Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.
Product
Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0117-2014·2013-11-06
Integra Camino Intracranial Pressure Monitoring Catheters Recalled for Missing MR Safety Labeling
Integra Limited is recalling specific Camino Intracranial Pressure Monitoring Catheters and Kits because they lack required labeling indicating they are unsafe in MRI environments.
Product
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that cont
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2013·2013-09-04
Integra Leyla Ball Joint Clamp Recalled for Potential Instability
Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.
Product
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-2458-2012·2012-10-03
Integra Limited Recalls Mayfield Horseshoe Gel Pads Due to Packaging Error
Integra Limited is recalling Mayfield Horseshoe Gel Pads because left and right pads were incorrectly packaged. No patient injuries or surgical delays were reported.
Product
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2457-2012·2012-10-03
Integra Limited Recalls Mispackaged MAYFIELD Horseshoe Gel Pads
Integra Limited is recalling 11 MAYFIELD Horseshoe Gel Pads from Lot 0938990 because left and right pads were incorrectly packaged. No patient injuries were reported.
Product
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2028-2012·2012-07-25
Integra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect
Integra Limited is recalling 108 Take-Apart Endoscopic Instruments because internal shaft components were out of specification.
Product
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument fo
Category
Medical Device
Distribution
Distributed nationwide